【０００１】技術分野 本発明は外科用ステープル装置とその装置によって形成された継ぎ目を補強す
る手段に関し、特に内視鏡手術において外科用ステープル装置により形成された
縫合部を補強する手段に関する。TECHNICAL FIELD The present invention relates to a surgical stapling device and a means for reinforcing a seam formed by the device, and more particularly to a means for reinforcing a suture formed by a surgical stapling device in endoscopic surgery.
【０００２】背景技術 近年の外科処置において最も商業的に成功した革新の１つは外科用ステープラ
装置の開発である。こうした装置は患者の組織の長い部分を同時に切断及び封鎖
するように設計されており、こうした処置の時間と危険度を大きく減少させた。
通常、外科用ステープラは２つのステープラアームを備えており、その１つは多
数のステープルの２つかそれ以上の線を有し、第２のものは各ステープルを閉鎖
位置に折り曲げる対応する手段を有している。多くの場合、外科用刃が装置に含
まれ、ステープルの線の間で組織を迅速に切断する。切断刃を利用するこうした
ステープル装置は「吻合ステープラ」と呼ばれ、切断刃なしで使用されるものは
「非吻合ステープラ」と呼ばれる。BACKGROUND OF THE INVENTION One of the most commercially successful innovations in surgical procedures in recent years has been the development of surgical stapler devices. Such devices are designed to simultaneously cut and block long sections of patient tissue, greatly reducing the time and risk of such procedures.
Surgical staplers typically include two stapler arms, one having two or more lines of multiple staples and a second having corresponding means for folding each staple into a closed position. is doing. Often, a surgical blade is included in the device to quickly cut tissue between the staple lines. Such stapling devices that utilize a cutting blade are called "anastomotic staplers" and those used without a cutting blade are called "non-anastomotic staplers".
【０００３】 通常の吻合ステープラの操作の際、２つのステープラアームが切断対象の組織
の周囲に配置された後互いに堅固に固定される。１つの動作で、外科医がステー
プラ装置を作動させると、それは同時に組織を通じてステープルの２つかそれ以
上の線を設置し、ステープル線の中央に線を切り込む。この方法で、医師は一度
に約８ｃｍまでの組織を迅速に切断及び封鎖することができる。この処置は、は
さみまたは外科用メスで切断した後縫合術によって切開部を苦労して封鎖する従
来の処置を使用するよりはるかに早い。その結果、手術部位からの出血時間を最
小にし、手術を完了するまでの速度を大きく向上させることで、患者の治療は劇
的に改良される。During normal anastomotic stapler operation, two stapler arms are placed around the tissue to be cut and then rigidly secured to each other. In one operation, when the surgeon activates the stapler device, it simultaneously places two or more lines of staple through the tissue and cuts the line in the center of the staple line. In this way, the physician can quickly cut and seal up to about 8 cm of tissue at a time. This procedure is much faster than using the traditional procedure of painfully sealing the incision by suturing after cutting with scissors or a scalpel. As a result, treatment of the patient is dramatically improved by minimizing bleeding time from the surgical site and greatly increasing the rate of completion of the surgery.
【０００４】 大部分の処置では、ステープルが患者の組織に直接接触する裸ステープルの使
用が一般に許容できる。組織自体の統合性が普通、ステープルが組織から外れ治
癒が行われる前に縫合部を傷つけることを防止する役目を果たす。しかし、状況
によっては、封鎖された組織が脆弱すぎてステープルを定位置に確実に保持でき
ないことがある。こうした場合、組織はステープルの線の位置またはその近くで
裂ける傾向があり、治癒を遅らせ、深刻な合併症につながることがある。[0004] For most procedures, the use of bare staples, where the staples come into direct contact with the patient's tissue, is generally acceptable. The integrity of the tissue itself usually serves to prevent the staples from injuring the suture before it detaches from the tissue and heals. However, in some circumstances, the blocked tissue may be too fragile to reliably hold the staples in place. In such cases, the tissue tends to tear at or near the staple line, which may delay healing and lead to serious complications.
【０００５】 脆弱な組織が特に問題になる１つの分野は、肺組織、特に肺気腫または同様の
状態に冒された肺組織におけるステープラ装置の使用である。罹患した肺組織は
非常に脆弱で、極端な場合には、保護されていないステープルの線によって容易
に破断する。気腫性嚢胞切除及び容量縮小術といった罹患肺組織に対する手術で
の外科用ステープルの使用が増大するに連れ、外科用ステープルまたは外科用ス
テープル固定処置により組織が破断してしまうことから脆弱な組織を保護する何
らかの確実な手段を開発することが次第に重要になった。One area in which fragile tissue is of particular concern is the use of stapler devices in lung tissue, particularly lung tissue affected by emphysema or similar conditions. Affected lung tissue is very fragile and, in extreme cases, is easily broken by unprotected staple lines. As the use of surgical staples in surgical procedures on diseased lung tissue, such as emphysematous cystectomy and volume reduction surgery, has increased the use of surgical staples or surgical stapling procedures to destroy fragile tissue. It has become increasingly important to develop some reliable means of protection.
【０００６】 こうした問題を解決しようとする製品の１つは、ミネソタ州セントポールのＢ
ｉｏ−Ｖａｓｃｕｌａｒ，Ｉｎｃ．から入手可能なＰＥＲＩ−ＳＴＲＩＰＳ（登
録商標）ステープルの線の補強スリーブである。この製品は、肺切除術で使用す
るよう指定され、ステープルの線を支持し、ステープル穴を通じて発生しうる空
気の漏れを防止する役目を果たす。このスリーブは３つの構成部分からなる構造
であって、（１）加工されたウシ心膜組織の薄い細片が（２）縫合線によって（
３）ポリエチレンのバッキング材料に取り付けられ、管状スリーブを形成する。
この３つの構成部分からなるスリーブが外科用ステープラの各アーム上を摺動さ
れ、ウシ心膜組織が各ステープラアームの作用面に注意深く位置決めされる。One product that attempts to solve these problems is B in St. Paul, Minnesota.
io-Vascular, Inc. Is a line reinforcement sleeve of PERI-STRIPS® staple available from This product is designated for use in pulmonary resection and serves to support the staple lines and prevent possible air leaks through the staple holes. This sleeve has a structure consisting of three parts: (1) a thin strip of processed bovine pericardial tissue (2) with suture lines (
3) Attached to a polyethylene backing material to form a tubular sleeve.
The three-component sleeve is slid over each arm of the surgical stapler, and bovine pericardial tissue is carefully positioned on the working surface of each stapler arm.
【０００７】 手術の際、外科医はウシ心膜組織と患者の肺組織の両方をステープルで固定し
切断して、肺切除術を行う。ステープルが定位置に配置されると、外科医はウシ
心膜細片を定位置に保持する縫合線を切断し、ポリエチレンバッキング材料と縫
合線を除去しなければならない。During surgery, a surgeon performs a pulmonary resection by fixing and cutting both bovine pericardial tissue and the patient's lung tissue with staples. Once the staples are in place, the surgeon must cut the suture that holds the bovine pericardial strip in place and remove the polyethylene backing material and the suture.
【０００８】 ＰＥＲＩ−ＳＴＲＩＰＳは肺組織の破断を防止する上での改良となるが、この
製品は非常に多くの欠点を有している。第１に、ウシ心膜組織を使用することで
非常に多くの取扱い上の問題と費用が発生する。この天然組織は使用前に防腐剤
（例えば酸化プロピレン）の中で保存しなければならず、防腐剤は使用に先立っ
て食塩水洗浄によって注意深く除去しなければならない。これはスリーブの使用
に先立つ作業員の時間と労力の不必要な浪費と考えられる。洗浄後も、ＰＥＲＩ
−ＳＴＲＩＰＳスリーブは、使用前にずっと湿らせておく必要がある。Although PERI-STRIPS is an improvement in preventing rupture of lung tissue, this product has numerous drawbacks. First, the use of bovine pericardial tissue creates numerous handling problems and costs. This natural tissue must be preserved in a preservative (eg propylene oxide) before use, and the preservative must be carefully removed by saline wash prior to use. This is considered an unnecessary waste of time and effort of the operator prior to using the sleeve. After cleaning, PERI
-STRIPS sleeves should be moistened all the time before use.
【０００９】 こうした要求の厳しい取扱い上の性質のため、ＰＥＲＩ−ＳＴＲＩＰＳスリー
ブを速やかに利用することは非常に困難である。その結果、普通外科医は、十分
な数を常に準備し用意しておくために手術の度毎にいくつかの細片を無駄にしな
ければならない。ＰＥＲＩ−ＳＴＲＩＰＳスリーブはかなり高価で、普通通常の
肺切除術で使用される最も高価な単一の用具の１つであるので、使用しないかも
しれない余分のスリーブを準備する必要があるということは些細な問題ではない
。Due to such demanding handling properties, rapid utilization of PERI-STRIPS sleeves is very difficult. As a result, ordinary surgeons must waste some strips with each surgery to ensure that a sufficient number is always prepared and available. Since the PERI-STRIPS sleeve is quite expensive and is one of the most expensive single tools commonly used in normal lung resection, the need to prepare extra sleeves that may not be used means It's not a trivial matter.
【００１０】 ＰＥＲＩ−ＳＴＲＩＰＳスリーブにまつわるもう１つの問題は、それが多数の
構成部分からなる構造であるということである。外科医は、ステープラの作動前
にスリーブが適切に位置調整されることと、ステープルがウシ心膜組織のみを通
じて打ち込まれることに特に注意しなければならない。ポリエチレンバッキング
材料は人間への移植用に承認されていないので、ウシ心膜組織だけがステープル
の線に取り付けられ、バッキング材料が全て除去されることが極めて重要である
。Another problem with PERI-STRIPS sleeves is that it is a multi-part construction. The surgeon must be particularly careful that the sleeve is properly aligned prior to actuation of the stapler and that the staples are driven through bovine pericardial tissue only. Since polyethylene backing material is not approved for human implantation, it is extremely important that only bovine pericardial tissue be attached to the staple line and that all backing material be removed.
【００１１】 ＰＥＲＩ−ＳＴＲＩＰＳスリーブにまつわる他の問題には、はさみまたは外科
用メスを利用して２つの材料を一緒に保持している縫合線を切断する必要、天然
動物組織の通常の差異による製品性能のばらつき、ウシ心膜組織を通じて切断す
ることの困難さ、及びＰＥＲＩ−ＳＴＲＩＰＳスリーブの準備が適切に行われな
かった場合の汚染または免疫問題の可能性が含まれる。こうした全ての制約にか
かわらず、ＰＥＲＩ−ＳＴＲＩＰＳ補強スリーブは依然として肺切除術を行う外
科医の第１の選択肢である。Other problems associated with PERI-STRIPS sleeves include the need to use scissors or a scalpel to cut the suture holding the two materials together, product performance due to normal differences in natural animal tissue. Variability, difficulty cutting through bovine pericardial tissue, and possible contamination or immune problems if the PERI-STRIPS sleeve was not properly prepared. Despite all these constraints, the PERI-STRIPS reinforcement sleeve remains the surgeon's first choice for pneumonectomy.
【００１２】 こうした欠点のいくつかに取り組もうと努力して、脈管移植片または同様の装
置から切り取られたポリテトラフルオロエチレン（ＰＴＦＥ）の細片のような人
工移植可能材料からステープル補強装置を形成することが試みられた。材料の細
片は、ステープラアームの周囲に巻き付けられた縫合線の環によってステープラ
アームの作用面に保持される。ステープルが細片を通して打ち込まれると、外科
医は縫合線を切断して装置を手術部位から除去しなければならない。この技術は
、準備、設置及びこの形態の細片の使用が困難なため広く利用されなかった。さ
らに、人工移植可能材料の比較的細い細片を使用することは、ウシ心膜組織の細
片を使用する際に遭遇するのと同様の中心合わせの問題を有する。どちらの場合
でも、細片は外科用アームの作用面に注意深く中心合わせされなければならず、
さもないと適切なステープルの補強が得られない。In an effort to address some of these shortcomings, staple reinforcement devices have been formed from artificial implantable materials, such as strips of polytetrafluoroethylene (PTFE) cut from a vascular graft or similar device. Was attempted. The strip of material is held on the working surface of the stapler arm by a loop of suture wrapped around the stapler arm. Once the staples have been driven through the strip, the surgeon must cut the suture and remove the device from the surgical site. This technique has not been widely used due to the difficulty of preparation, installation and use of this form of strip. Moreover, the use of relatively fine strips of artificial implantable material has similar centering problems to those encountered when using strips of bovine pericardial tissue. In both cases, the strip must be carefully centered on the working surface of the surgical arm,
Otherwise, proper staple reinforcement cannot be obtained.
【００１３】 他に、ＭｃＫｅａｎ他への米国特許第５，５４２，５９４号の場合のように、
ピンまたはクリップでステープラに取り付けられた補強細片を使用することが開
示された。Ｇｒａｖｅｎｅｒへの米国特許第５，４４１，１９３号は、より広い
範囲の組織厚さに対応するためにステープラアンビルに接着された弾性フィルム
の使用を教示する。こうした装置はＰＥＲＩ−ＳＴＲＩＰＳ製品に固有の取扱い
上の問題のいくつかに取り組んでいるが、それらは固有の欠陥を有している。材
料を定位置に固定するピン、クリップまたは接着剤を使用する必要があるが、そ
れらを製造業者または外科スタッフが行うことは容易ではない。さらに、補強細
片が製造業者によって事前に設置されている場合、自分が適当と考えるように補
強材料を使用するかしないかを選択する外科医の能力が制限される。Alternatively, as in US Pat. No. 5,542,594 to McKean et al.
It has been disclosed to use a reinforcing strip attached to the stapler with a pin or clip. US Pat. No. 5,441,193 to Gravener teaches the use of elastic films adhered to a stapler anvil to accommodate a wider range of tissue thicknesses. While such devices address some of the handling issues inherent in PERI-STRIPS products, they have their own deficiencies. The use of pins, clips or adhesives that hold the material in place is not easy for manufacturers or surgical staff to do. Furthermore, if the reinforcement strips were pre-installed by the manufacturer, the surgeon's ability to choose whether or not to use the reinforcement material as he sees fit is limited.
【００１４】 こうした欠陥は全て、先の出願に記載されている発明によって取り扱われてい
る。この出願の好適な装置は、矩形断面を有し、スリーブとステープラアームの
間にて摺動摩擦ばめが行われる生体適合性材料のスリーブを利用する。これによ
ってスリーブは、時間のかかる設置手段を使用する必要なしに、要求がある時は
いつでも、外科スタッフの必要に応じて速やかに設置することができる。ポリテ
トラフルオロエチレン（ＰＴＦＥ）及び特に延伸膨張ＰＴＦＥといった容易に取
り扱いできるポリマー材料からスリーブを構成することで、スリーブは特別な準
備または取扱い手順を必要としない。その結果、スリーブは必要に応じてステー
プラに即座に設置できる。さらに、スリーブは引き裂き線を備えることがあり、
スリーブが定位置に固定された際余分な材料を容易に分離できるようにする。All these deficiencies are addressed by the invention described in the earlier application. The preferred device of this application utilizes a sleeve of biocompatible material having a rectangular cross-section with a sliding friction fit between the sleeve and the stapler arm. This allows the sleeve to be quickly installed as needed by the surgical staff, when required, without having to use time-consuming installation means. By constructing the sleeve from easily handleable polymeric materials such as polytetrafluoroethylene (PTFE) and especially expanded PTFE, the sleeve does not require special preparation or handling procedures. As a result, the sleeve can be immediately installed on the stapler if desired. In addition, the sleeve may have tear lines,
Allows easy removal of excess material when the sleeve is locked in place.
【００１５】 本出願の発明は内視鏡手術用ステープラに設置して使用することもできるが、
内視鏡手術用ステープラは従来のステープラ装置と異なったいくつかの要求を有
している。内視鏡手術用ステープラは、ステープラを小さな切開部を通じて挿入
した後患者の体内で外科医によって遠隔操作できるように構成される。これを達
成するために、大部分の内視鏡手術用ステープラは、はさみの方式で固定された
ピボットで互いに結合された短いステープラアーム（または「顎」）を備えてい
る。ステープラアームは一般に、延長棒により外科医の作動手段から離れて設置
される。The invention of the present application can be installed and used in a stapler for endoscopic surgery.
Endoscopic surgical staplers have several requirements that differ from conventional stapler devices. An endoscopic surgical stapler is configured to be remotely operable by a surgeon within a patient after inserting the stapler through a small incision. To achieve this, most endoscopic surgical staplers include short stapler arms (or "chins") that are joined together by pivots that are fixed in a scissor fashion. The stapler arm is generally placed away from the surgeon's actuation means by an extension rod.
【００１６】 この構造は多数の固有の問題を有する。第１に、ステープラアームのはさみ状
構造はピボットの中に組織を捉える傾向があることが判明した。これによって、
ピボット内の付着物の問題が発生することがある。さらに、内視鏡手術用ステー
プラが遠隔操作を必要とする性質のため、余分な補強材料を手術部位から除去す
ることが困難になることがある。最後に、補強材料を遠隔アームに確実に保持す
ることは外科医の主要な問題である。This structure has a number of inherent problems. First, it was found that the scissor-like structure of the stapler arm tends to trap tissue within the pivot. by this,
Problems with deposits in the pivot can occur. In addition, the remote manipulation nature of endoscopic surgical staplers can make it difficult to remove excess stiffening material from the surgical site. Finally, reliable retention of the reinforcement material on the remote arm is a major problem for the surgeon.
【００１７】 こうした問題を考慮すると、外科用ステープルの線を完全に保護し、かつ準備
と使用が容易な内視鏡手術用ステープラで使用するための改良されたステープル
の線の補強材料を提供することが本発明の主要な目的である。In view of these issues, there is provided an improved staple line stiffening material for use in endoscopic surgical staplers that provides complete protection of the surgical staple line and is easy to prepare and use. That is the main object of the present invention.
【００１８】 内視鏡手術用ステープラに固有の問題に対処する改良されたステープルの線の
補強材料を提供することが本発明の他の目的である。It is another object of the present invention to provide an improved staple line stiffening material that addresses the problems inherent in endoscopic surgical staplers.
【００１９】 本発明のこれらと他の目的は、以下の明細書を読むことにより明らかになるだ
ろう。These and other objects of the invention will be apparent upon reading the following specification.
【００２０】発明の開示 本発明は、内視鏡手術による外科用ステープラのための外科用ステープルを補
強するための改良された装置である。本発明は外科用ステープルを使用する広い
範囲の外科処置に適用されるのに適しているが、肺切除術における肺組織といっ
た脆弱な組織について適用されるのに特に適している。本発明の装置は、手術部
位を封鎖する方法を改良する際の重要な用具と考えられ、外科用ステープルを通
るかまたはその周囲の手術部位において破断または漏れが起こってしまう可能性
を減少させる。DISCLOSURE OF THE INVENTION The present invention is an improved device for reinforcing surgical staples for endoscopic surgical staplers. While the present invention is suitable for application in a wide range of surgical procedures using surgical staples, it is particularly suitable for application to fragile tissue such as lung tissue in pneumonectomy. The device of the present invention is considered to be an important tool in improving the method of sealing a surgical site, reducing the likelihood of breakage or leakage at the surgical site through or around surgical staples.
【００２１】 本発明の装置は、中央で回転される１対の外科用ステープラアーム上に挿入さ
れるのに適したスリーブを備えている。スリーブは、各ステープラアームに沿っ
て延びていると共にステープラアームを結合するピボット上にて遮蔽を行う作用
面を備えている。各ステープラアームを取り囲み、装置の定位置に作用面を保持
する管状構造体が提供される。好適な管状構造体は、ステープラアームとスリー
ブの間において摩擦ばめを行う際の補助となる本質的に矩形の断面寸法を備えて
いる。The device of the present invention comprises a sleeve suitable for insertion over a pair of centrally rotated surgical stapler arms. The sleeve has a working surface that extends along each stapler arm and provides shielding on a pivot that joins the stapler arms. A tubular structure is provided that surrounds each stapler arm and holds the working surface in place on the device. The preferred tubular structure has an essentially rectangular cross-sectional dimension to aid in the friction fit between the stapler arm and the sleeve.
【００２２】 本発明のスリーブにはまた、好適には引き裂き線または他の手段を備え、ステ
ープルの設置後、余分なスリーブ材料を手術部位から容易に分離できるようにさ
れている。さらに、スリーブには余分なスリーブ材料を手術部位から除去する際
の補助となる保持手段が含まれることがある。好適な装置は多孔性ポリテトラフ
ルオロエチレン（ＰＴＦＥ）及び最も好適には延伸膨張ＰＴＦＥから形成される
。The sleeve of the present invention is also preferably provided with a tear line or other means to facilitate the separation of excess sleeve material from the surgical site after the placement of the staples. In addition, the sleeve may include retention means to assist in removing excess sleeve material from the surgical site. The preferred device is formed from porous polytetrafluoroethylene (PTFE) and most preferably expanded PTFE.
【００２３】 本発明のスリーブは、以前のステープルのための補強装置に比べ、内視鏡手術
のための外科用ステープラに対して準備すること及び使用することがはるかに容
易でなる。さらに、本発明のスリーブの固有の構造のため、内視鏡手術用ステー
プラは以前可能だった以上に有効に機能できる。The sleeve of the present invention is much easier to prepare and use for surgical staplers for endoscopic surgery than previous stiffening devices for staples. In addition, the unique construction of the sleeve of the present invention allows endoscopic surgical staplers to function more effectively than previously possible.
【００２４】発明を実施するための最良の形態 本発明の作用は、添付の図面を参照して以下の説明を読むことにより明らかに
なるであろう。BEST MODE FOR CARRYING OUT THE INVENTION The operation of the present invention will be apparent from the following description with reference to the accompanying drawings.
【００２５】 本発明は外科用ステープラによって形成されるステープルの線を補強する際に
使用される改良された装置である。The present invention is an improved device for use in stiffening staple lines formed by surgical staplers.
【００２６】 図１には従来の外科用ステープラ１０が示される。ステープラ１０は、共に固
定され得る２つの別個の半分の部分１２、１４を備えている。半分の部分１２及
び１４は各々、それぞれのためのハンドル１６ａ及び１６ｂを有し、それにより
ステープラの操作が可能になる。第１の半分の部分１２には１列以上の外科用ス
テープルを装着した第１ステープラアーム１８がある。対応する第２ステープラ
アーム２０は第２の半分の部分１４にあり、第１ステープラアーム１８に収容さ
れた各ステープルを閉鎖位置に曲げる手段を有する。ステープルを曲げるこの手
段は、通常、各々が第１ステープラアーム１８に収容されたステープルの１つに
対応する一連の輪郭の付いた溝を備えている。最後に、半分の部分の１つは、各
ステープルを打ち出す作動アーム２２を有する。吻合ステープラ装置では、作動
アーム２２はステープルを打ち出すと共に切断刃２４を作動させる。切断刃２４
は少なくとも２列のステープルの間に向けられ、各列のステープルにより切断動
作と同時に切断刃の両側における封鎖が行われ得る。A conventional surgical stapler 10 is shown in FIG. The stapler 10 comprises two separate halves 12, 14 that can be secured together. The halves 12 and 14 each have a handle 16a and 16b for each, which allows manipulation of the stapler. The first half portion 12 has a first stapler arm 18 loaded with one or more rows of surgical staples. A corresponding second stapler arm 20 is in the second half portion 14 and has means for bending each staple contained in the first stapler arm 18 to the closed position. This means for bending the staples typically comprises a series of contoured grooves each corresponding to one of the staples contained in the first stapler arm 18. Finally, one of the halves has an actuating arm 22 that fires each staple. In the anastomotic stapler device, the actuation arm 22 fires the staples and actuates the cutting blade 24. Cutting blade 24
Are oriented between at least two rows of staples, and each row of staples can effect a cutting operation and a blocking on both sides of the cutting blade.
【００２７】 動作の際、ステープラ１０の２つの半分の部分１２、１４は、封鎖すべき組織
の両側に位置決めされた各ステープラアーム１８、２０と共に固定される。アー
ム１８、２０が適切に位置決めされていることを外科医が確認すると、作動アー
ム２２が前方に移動し、ステープルを打ち出して手術部位を封鎖する。吻合ステ
ープラ装置では、切断刃２４によって組織を薄く切るのと同時にステープルが打
ち出される。その結果、患者の組織の切断及び封鎖が迅速で正確に行われ、以前
の切断及び縫合技術よりはるかに迅速である。In operation, the two halves 12, 14 of the stapler 10 are secured with each stapler arm 18, 20 positioned on either side of the tissue to be sealed. When the surgeon confirms that the arms 18, 20 are properly positioned, the actuating arm 22 moves forward, ejecting the staples and sealing the surgical site. In the anastomotic stapler device, the cutting blade 24 simultaneously cuts the tissue and ejects the staples. As a result, cutting and sealing of the patient's tissue is quick and accurate, much faster than previous cutting and suturing techniques.
【００２８】 すでに示したように、市販のステープラは切断及び封鎖を行う多くの場合にお
いて良好に機能するが、肺気腫患者の肺組織のような弱くて壊れやすい組織にス
テープルを配置する場合に問題が生じることが経験されている。何らかの形態で
ステープルの補強を行う必要性が認識されていたが、本発明以前には完全に十分
なステープルのための補強装置は利用できなかった。As previously indicated, commercial staplers perform well in many cases of cutting and sealing, but have problems when placing staples on weak and fragile tissue, such as lung tissue of patients with emphysema. Has been experienced to occur. Although the need for some form of stiffening was recognized, prior to the present invention, no fully sufficient stiffening device was available.
【００２９】 本発明では、こうした装置について以前に経験された問題の多くを解決するス
テープルのための補強装置が提供される。本発明のステープルのための補強装置
２６の第１実施形態が図１及び図２に示される。この装置２６は、外科用ステー
プルの列または線を受け止める少なくとも１つの面３０と、ステープラアーム１
８、２０を取り囲み、装置２６を定位置に保持する少なくとも１つの側面／背面
壁３２とを有するスリーブ２８を備えている。開口３４がスリーブ２８の少なく
とも一端に設けられ、ステープラアームにスリーブを取付けるのが可能になる。The present invention provides a stiffening device for staples that solves many of the problems previously experienced with such devices. A first embodiment of a stiffening device 26 for staples of the present invention is shown in FIGS. The device 26 includes at least one surface 30 for receiving a row or line of surgical staples and a stapler arm 1.
A sleeve 28 is provided that surrounds 8, 20 and has at least one side / back wall 32 that holds the device 26 in place. An opening 34 is provided in at least one end of the sleeve 28 to allow attachment of the sleeve to the stapler arm.
【００３０】 いくつかの以前の管状のステープルのための補強装置と異なり、本発明の装置
は全体が移植可能材料から形成される。これによって以前のステープル補強装置
よりかなり少ない注意で装置を取付け使用することができる。例えば、装置のわ
ずかな位置合わせ不良があっても、そのために患者の内部に移植可能でない材料
が不用意に取り付けられたり、組織を保護する補強材料の量が不十分になったり
することはない。Unlike some prior stiffening devices for tubular staples, the device of the present invention is formed entirely of implantable material. This allows the device to be installed and used with considerably less care than previous staple reinforcement devices. For example, slight misalignment of the device does not result in inadvertent attachment of non-implantable material inside the patient or inadequate amount of reinforcing material to protect the tissue. .
【００３１】 図１及び図２の実施形態では、壁３２は本質的に３つの他の作用面３５、３６
及び３７を備えている。この構造によって、面３０、３５、３６及び３７の何れ
か１つが患者の組織中でステープルを受け止め、補強することができる。その結
果、使用前にスリーブを取付け中心合わせするために外科チームに必要とされる
注意と操作が少なくなる。In the embodiment of FIGS. 1 and 2, the wall 32 is essentially three other working surfaces 35, 36.
And 37. This construction allows any one of surfaces 30, 35, 36 and 37 to receive and reinforce staples in the tissue of the patient. As a result, less attention and manipulation is required by the surgical team to install and center the sleeve prior to use.
【００３２】 好適には、装置２６は、全て参考として本出願の記載に組み込まれている米国
特許第３，９５３，５６６号、第３，９６２，１５３号、第４，０９６，２２７
号及び第４，１８７，３９０号によって製造されるもののような多孔性ポリテト
ラフルオロエチレン（ＰＴＦＥ）、特に延ばされたまたは延伸膨張ＰＴＦＥから
構成されている。これらの特許の教示によってＰＴＦＥを加熱し急速に膨張させ
ることで、結果として得られる材料は膨張された方向で並外れた強さを示す。Suitably, device 26 is US Pat. Nos. 3,953,566, 3,962,153, 4,096,227, all of which are incorporated herein by reference.
And porous polytetrafluoroethylene (PTFE), such as those manufactured by No. 4,187,390, especially expanded or expanded PTFE. By heating and rapidly expanding PTFE according to the teachings of these patents, the resulting material exhibits extraordinary strength in the expanded direction.
【００３３】 ＰＴＦＥ、特に延伸膨張ＰＴＦＥは、移植可能材料として使用するのに特に適
したものになる非常に多くの特性を有している。第１に、この材料は高度に不活
性で、滅菌可能で、生体適合性である。その結果、これは脈管移植片及び様々な
他の移植可能チューブ及びシート材料として広く利用されている。さらに、ＰＴ
ＦＥは非常に低い摩擦係数を有するので、ステープラアーム１８、２０に材料を
容易に摺動させたり除去したりできると共に、容易かつ滑らかに切断刃２４によ
って切断し外科用ステープルによって封鎖することができる。最後に、延伸膨張
ＰＴＦＥは選択的に延伸膨張させ、ステープルの引き抜きに耐えるために必要な
特別な強度を有し、装置の切断方向で容易に切断できるようにすることができる
。PTFE, especially expanded PTFE, has numerous properties that make it particularly suitable for use as an implantable material. First, the material is highly inert, sterilizable, and biocompatible. As a result, it is widely used as a vascular graft and a variety of other implantable tube and sheet materials. Furthermore, PT
The FE has a very low coefficient of friction so that the stapler arms 18, 20 can easily slide and remove material, and can be easily and smoothly cut by the cutting blade 24 and sealed by surgical staples. . Finally, the expanded PTFE can be selectively expanded to have the extra strength needed to withstand the pulling out of the staples so that it can be easily cut in the cutting direction of the device.
【００３４】 本発明と共に使用する延伸膨張ＰＴＦＥの好適なスリーブは以下の方法で形成
される。微粉末ＰＴＦＥ樹脂は、無臭ミネラルスピリットのような潤滑剤と、コ
ンパウンドが形成されるまで混合される。使用される潤滑剤の量は、押出し成形
前に粒子を剪断する可能性を最小にするようにＰＴＦＥ樹脂の主要な粒子を潤滑
する十分なものであるべきである。次にコンパウンドは圧縮されてビレットとな
り、ラム形押出し成形機によるなどして押出し成形され、凝集性押出し物を形成
する。３０：１〜３００：１の圧延比が使用される（すなわち、圧延比＝押出し
シリンダの断面積÷押出し金型の断面積である）。多くの適用例では、７５：１
〜１５０：１の圧延比が好適である。次に潤滑剤が、揮発によるなどして除去さ
れる。望ましい場合、押出し製品はさらに、少なくとも１つの方向に、元の長さ
の１．１〜５０倍に膨張せしめられる。膨張は、乾燥した凝集性押出し物を一連
の回転加熱ローラまたはプレートの上を通過させることによって達成される。チ
ューブは高温炉の中で延ばされ、管状構造を維持する。A suitable sleeve of expanded PTFE for use with the present invention is formed by the following method. The finely powdered PTFE resin is mixed with a lubricant such as odorless mineral spirits until a compound is formed. The amount of lubricant used should be sufficient to lubricate the primary particles of PTFE resin so as to minimize the possibility of shearing the particles prior to extrusion. The compound is then compressed into a billet and extruded, such as with a ram extruder, to form a coherent extrudate. A rolling ratio of 30: 1 to 300: 1 is used (ie rolling ratio = extrusion cylinder cross-sectional area / extrusion die cross-sectional area). 75: 1 in many applications
A rolling ratio of ~ 150: 1 is preferred. The lubricant is then removed, such as by volatilization. If desired, the extruded product is further expanded in at least one direction by 1.1 to 50 times its original length. Expansion is accomplished by passing the dried cohesive extrudate over a series of rotating heated rollers or plates. The tube is stretched in a high temperature furnace to maintain the tubular structure.
【００３５】 最後に、製品は熱硬化（「アモルファラス固定」とも呼ばれる）され、材料を
最終膨張状態に保持する。これは材料を約３２７〜３８０℃の熱に約２５秒から
約４分またはそれ以上さらすことによって達成される。Finally, the product is heat set (also called "amorphous fixing"), holding the material in its final expanded state. This is accomplished by exposing the material to heat of about 327-380 ° C. for about 25 seconds to about 4 minutes or longer.
【００３６】 本発明として使用される管状構造体を形成するため、押出し成形が、円形、半
円形、三角形、矩形または他の閉鎖リングダイによって行われ、管状製品が提供
されることが好適である。金型は、最終製品が望ましいステープラアームにぴた
りとはまるような寸法である。To form the tubular structure used as the present invention, extrusion is preferably performed by a circular, semi-circular, triangular, rectangular or other closing ring die to provide a tubular product. . The mold is sized so that the final product will fit snugly on the desired stapler arm.
【００３７】 また、管状構造は、延伸膨張材料のシートまたはテープを形成した後シートま
たはテープをまいて管状形態にすることによっても形成される。これは、縦巻き
（すなわち、「紙巻き煙草」を巻く方法）または螺旋巻き（例えばマンドレルま
たは同様の構造物の上に巻く）といった何らかの適切な手段によって達成される
。巻かれた製品は接着、熱結合、機械的手段（例えば縫合縫い目）または同様の
手段によって製品自体に結合され、ステープラアームの上に取り付けられるスリ
ーブを形成する。本発明の意図された範囲から逸脱することなく、接着剤または
縫合線といった少量の材料を使用して管状構造を互いに結合することは、本発明
により考慮されていることが理解されるべきである。The tubular structure is also formed by forming a sheet or tape of stretch-expandable material and then rolling the sheet or tape into a tubular form. This is accomplished by any suitable means such as longitudinal wrapping (i.e., a "cigarette" method) or spiral wrapping (e.g., on a mandrel or similar structure). The rolled product is bonded to the product itself by gluing, heat bonding, mechanical means (eg stitching seams) or similar means to form a sleeve mounted on the stapler arm. It should be understood that it is contemplated by the present invention to join tubular structures together using a small amount of material such as an adhesive or suture without departing from the intended scope of the present invention. .
【００３８】 本発明の範囲を制限しようと意図するものではないが、最終製品は好適には、
２：１〜６：１またはそれ以上（例えば１０：１）の膨張／拡張比、約２〜９０
μｍのフィブリル長さ、約１０ｋｇ以上の縦強度、約５ｋｇ以上の横強度、０．
８〜１．５ｇ／ｃｃの密度、及び約０．１２５〜２．５ｍｍの平均壁厚さといっ
た範囲の特性を有する延伸膨張ＰＴＦＥ構造を備えている。While not intending to limit the scope of the invention, the final product preferably
Expansion / expansion ratio of 2: 1 to 6: 1 or higher (eg 10: 1), about 2-90
A fibril length of 10 μm, a longitudinal strength of about 10 kg or more, a lateral strength of about 5 kg or more,
Equipped with expanded PTFE structure having properties ranging from 8-1.5 g / cc density and average wall thickness of about 0.125-2.5 mm.
【００３９】 こうした各特性は従来の方法で測定される。小繊維長さは、試料の走査型電子
顕微鏡写真（ＳＥＭ）で測定される延伸膨張ＰＴＦＥ材料の試料のノード間に延
びるフィブリルの平均長さによって決定される。縦及び横強度は、Ｉｎｓｔｒｏ
ｎ Ｃｏｒｐｏｒａｔｉｏｎから入手可能なＩＮＳＴＲＯＮ引張り試験機のよう
な引張り強度試験機を使用して決定される。密度は測定された試料の重量を計算
された試料の容積で除算することにより決定される。平均壁厚さは、カリパスを
使用すること、あるいは、ＳＥＭから測定することのような従来の手段によって
決定される。Each of these properties is measured by conventional methods. The fibril length is determined by the average length of fibrils extending between the nodes of a sample of expanded PTFE material as measured by scanning electron micrograph (SEM) of the sample. Vertical and horizontal strength is Instro
n tensile strength tester, such as the INSTRON tensile tester available from N Corporation. Density is determined by dividing the measured sample weight by the calculated sample volume. The average wall thickness is determined by conventional means such as using calipers or measuring from SEM.
【００４０】 本発明での使用に適した材料は多数の形態で市販されている。例えば、外科用
ステープラアーム上で使用するために修正される延伸膨張ＰＴＦＥの管状構造物
は、アリゾナ州フラッグスタッフのＷ．Ｌ．Ｇｏｒｅ ＆ Ａｓｓｏｃｉａｔｅ
ｓ，Ｉｎｃ．から、ＧＯＲＥ−ＴＥＸ（登録商標）の補綴脈管移植片の形態で市
販されている。さらに、本発明のスリーブに構成できる延伸膨張ＰＴＦＥのシー
ト及びテープは、メリーランド州エルクトンのＷ．Ｌ．Ｇｏｒｅ ＆ Ａｓｓｏ
ｃｉａｔｅｓ，Ｉｎｃ．のＧＯＲＥ−ＴＥＸ（登録商標）を含め、多数の供給源
から広範な形態で市販されている。Materials suitable for use in the present invention are commercially available in numerous forms. For example, a modified expanded PTFE tubular structure modified for use on a surgical stapler arm is described by W.F. of Flagstaff, Arizona. L. Gore & Associate
s, Inc. From GORE-TEX® in the form of a prosthetic vascular graft. Further, the expanded PTFE sheets and tapes that can be constructed into the sleeves of the present invention are described in W.L. of Elkton, MD. L. Gore & Asso
Cities, Inc. Commercially available in a wide range of forms from a number of sources, including GORE-TEX.
【００４１】 好適ではないが、本発明と共に利用することが可能な移植可能材料には、ナイ
ロン、ポリプロピレン、ポリウレタン、シリコーン、ＤＡＣＲＯＮ（登録商標）
ポリマー等が含まれる。適用例によっては、ポリグリコール酸（ＰＧＡ）、ポリ
乳酸（ＰＬＡ）、ポリカプロラクトン、または天然動物膜といった生体吸収性移
植可能材料を使用することが望ましい場合がある。Although not preferred, implantable materials that can be utilized with the present invention include nylon, polypropylene, polyurethane, silicone, DACRON®.
Polymers and the like are included. For some applications it may be desirable to use bioabsorbable implantable materials such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone, or natural animal membranes.
【００４２】 ステープラの作動後、スリーブの取り付け面をスリーブの残りの部分から分離
する手段が本発明の装置に含まれることが特に好適である。これは多数の方法の
中、何れかの１つかそれ以上によって達成される。スリーブの管状構造はその形
成時に修正されてある範囲を選択的に弱くするので、その部分は容易に縦に裂け
る。スリーブが押出し成形によって形成される場合、これは、ある部分でスリー
ブの厚さを減少させ引き裂き線を形成するように押出し金型を修正することで達
成される。例えば、１つ以上の突起が金型を通過する押出し物の流れの中に配置
されることにより、製造される管状構造物の長手方向に沿って厚さが減少せしめ
られる。このように長手方向に弱められることにより、材料が長手方向に沿って
より容易に分離（または「破断」）するようになる。このように材料を制御して
分離させる何らかの構造をここでは「引き裂き線」と呼ぶ。It is particularly preferred that the device of the present invention includes means for separating the mounting surface of the sleeve from the rest of the sleeve after actuation of the stapler. This can be accomplished by any one or more of a number of methods. The tubular structure of the sleeve is modified during its formation to selectively weaken a certain area so that the portion easily tears vertically. If the sleeve is formed by extrusion, this is accomplished by modifying the extrusion die to reduce the thickness of the sleeve and create tear lines at certain points. For example, one or more protrusions are placed in the flow of extrudate through the mold to reduce the thickness along the length of the tubular structure being manufactured. This longitudinal weakening causes the material to more easily separate (or "break") along the longitudinal direction. Any structure that allows controlled separation of materials is called a "tear line" here.
【００４３】 引き裂き線の１つの例が図２に示される。この実施形態では、押出し成形され
るチューブは本質的に矩形の断面を有し、壁厚さは約０．１２５〜１．０ｍｍだ
が、約０．３７５〜０．８ｍｍが通常の厚さである。望ましい場合、最新のステ
ープラ装置と共に使用するために、壁厚さは約２．５ｍｍまで増大されることが
ある。このチューブを押出し成形する金型のコーナを修正することによって、コ
ーナの壁厚さは約２５〜７５％減少できるが、好適な減少度合いは約６５％であ
る。コーナの壁厚さを減少させることにより、スリーブの長手にわたって４つの
引き裂き線４０ａ、４０ｂ、４０ｃ、４０ｄが形成される。横方向張力がスリー
ブに加えられると、材料の分離が引き裂き線に沿って容易に発生し、分離はチュ
ーブの長手方向に容易に伝搬するので、バッキング材料が取り付け面から除去さ
れる。例えば面３０を取り付ける場合、バッキング材料３２の分離は、引き裂き
線４０ａ及び４０ｂに沿って引き裂くことにより達成される。One example of a tear line is shown in FIG. In this embodiment, the extruded tube has an essentially rectangular cross section with a wall thickness of about 0.125-1.0 mm, with a typical thickness of about 0.375-0.8 mm. . If desired, the wall thickness may be increased to about 2.5 mm for use with modern stapler devices. By modifying the corners of the die from which this tube is extruded, the wall thickness of the corners can be reduced by about 25-75%, with a preferred reduction of about 65%. By reducing the wall thickness of the corners, four tear lines 40a, 40b, 40c, 40d are formed over the length of the sleeve. When lateral tension is applied to the sleeve, the backing material is removed from the mounting surface as material separation easily occurs along the tear lines and the separation easily propagates along the length of the tube. For example, when attaching surface 30, separation of backing material 32 is accomplished by tearing along tear lines 40a and 40b.
【００４４】 分離をさらに容易にするために、小さな切れ目４３が引き裂き線４０の一端に
設けられ、引き裂き伝搬の開始が容易にされる。切れ目４３はステープラ作動の
前または後に外科人員によって形成されることがある。また、切れ目４１はスリ
ーブ製造業者によってスリーブに形成されることもある。To further facilitate separation, a small cut 43 is provided at one end of the tear line 40 to facilitate initiation of tear propagation. The incision 43 may be made by surgical personnel before or after actuation of the stapler. The cut 41 may also be formed in the sleeve by the sleeve manufacturer.
【００４５】 引き裂き線４０は、個々の必要に対処するために、スリーブの任意の望ましい
位置に形成され得ることが認識されるべきである。例えば、図２の実施形態では
、２つの折り目が面３５及び３７に長手方向に設けられている。引き裂き線４０
ｅ及び４０ｆが代替的または追加的にこれらの折り目に沿って形成され、取付け
後にスリーブを分離する異なった、または増大した選択肢が提供され得る。It should be appreciated that the tear line 40 may be formed at any desired location on the sleeve to address individual needs. For example, in the embodiment of Figure 2, two folds are provided longitudinally in faces 35 and 37. Tear line 40
e and 40f may alternatively or additionally be formed along these folds to provide different or increased options for separating the sleeve after attachment.
【００４６】 引き裂き線を形成するもう１つの方法では、スリーブの形成後に引き裂き線が
形成される。これは、選択的加熱またはスリーブ材料の変更により引き裂き線を
形成する（例えば、レーザまたは加熱切断用具の使用による）、望ましい引き裂
き線に沿ってスリーブを所定の厚さまで切削する（例えば、切削刃による）、機
械的に材料を変質させる（例えば、ピンチローラの使用による）、選択的に材料
を弱める等の方法により、引き裂きが必要な場所でスリーブ材料を剥離または修
正することによって達成される。In another method of forming the tear line, the tear line is formed after forming the sleeve. This creates a tear line by selective heating or modification of the sleeve material (e.g., by using a laser or heat cutting tool), and cuts the sleeve along the desired tear line to a predetermined thickness (e.g., by a cutting blade) ), Mechanically altering the material (e.g., by use of pinch rollers), selectively weakening the material, and the like, by peeling or modifying the sleeve material where tearing is required.
【００４７】 また、スリーブには、取付け後にスリーブの残りの部分が容易に分離するよう
にスリーブを十分に脆弱化させる一連の穴または同様の構造の刻み目が形成され
ることがある。これは、レーザで穴を形成する、パンチで穴を開ける、刃の付い
たピンチローラを使用する等の多数の手段、またはいくつかの説明された方法の
何らかの組合せによって達成される。Also, the sleeve may be formed with a series of holes or similar structured notches that sufficiently weaken the sleeve so that the rest of the sleeve is easily separated after installation. This is accomplished by a number of means, such as laser drilling, punching, using bladed pinch rollers, or some combination of some of the described methods.
【００４８】 引き裂き線が形成されると、取付け後の材料の分離は容易かつ迅速に達成でき
る。図５には、本質的に図１及び図２に示された構造である本発明の２つの装置
２６ａ、２６ｂの１つの例が示される。図示されるように、装置２６ａ及び２６
ｂは、ステープル４３によって、面３０ａ及び３０ｂに沿って組織の２つの部分
４４、４６に取り付けられる。組織の部分４４、４６は、吻合外科用ステープラ
を使用して切開線４８に沿って切り離され、それぞれステープルの線５０ａ、５
０ｂ及び５０ｃ、５０ｄによって封鎖される。Once the tear line is formed, the separation of the material after installation can be achieved easily and quickly. FIG. 5 shows one example of two devices 26a, 26b of the present invention, which is essentially the structure shown in FIGS. As shown, devices 26a and 26
b is attached by staple 43 to the two portions of tissue 44, 46 along surfaces 30a and 30b. The tissue portions 44, 46 are cut along an incision line 48 using an anastomotic surgical stapler, and staple lines 50a, 5 respectively.
Blocked by 0b and 50c, 50d.
【００４９】 ステープラが作動され、組織を切断及び封鎖すると、各スリープのバッキング
材料３２は、単に引き裂き線４０ａ及び４０ｂに沿って引き裂くだけで取り付け
られた面から分離できる。これは普通、ステープラアームがまだ切断部位付近に
ある状態でなされる。図５に示す例では、手術切断部４８とステープル４３の配
置に関して詳細に示した部分を隠さないようにするために、外科用ステープラが
切断部位に示されていない。図示されるように、バッキング材料３２ａ、３２ｂ
が除去されると、スリーブの作用面３０ａ、３０ｂだけがその位置に残る。Upon actuation of the stapler and cutting and sealing of the tissue, the backing material 32 of each sleep can be separated from its attached surface simply by tearing along tear lines 40a and 40b. This is usually done with the stapler arm still near the cutting site. In the example shown in FIG. 5, the surgical stapler is not shown at the cutting site to avoid obscuring the details shown with respect to placement of the surgical cut 48 and staple 43. As shown, the backing material 32a, 32b
Is removed, only the working surfaces 30a, 30b of the sleeve remain in place.
【００５０】 取り付けられた補強材料からステープラを容易に分離する引き裂き線を設ける
ことは、本発明の極めて有益な特徴であると考えられる。以前のスリーブ装置は
、利用されたステープルのための補強装置をバッキング材料とステープラ自体か
ら解放するために、何らかの形態の取り付け縫合線の切断または同様の操作を必
要とした。これは外科医にとって余分な工程であるが、手術部位に妨げられずに
アクセスできる多くの手術処置の場合特に煩わしいものではない。Providing a tear line that facilitates separation of the stapler from the attached stiffening material is considered a highly beneficial feature of the invention. Previous sleeve devices required some form of attachment suture cutting or similar operation to release the stiffening device for the utilized staples from the backing material and the stapler itself. This is an extra step for the surgeon, but is not particularly annoying for many surgical procedures where the surgical site is accessible unobstructed.
【００５１】 しかし、内視鏡手術における処置が増大するに連れ、手術部位へのアクセスが
故意に制限されているので、ステープラをステープル用補強材料から分離するた
めに追加切断工程を行う必要があることはかなり煩わしい。実際、ＰＥＲＩ−Ｓ
ＴＲＩＰＳ補強材料の場合存在するようなステープル補強材料に取り付けられた
移植可能でない材料が存在する場合、外科医は、処置を終了する前に内視鏡手術
部位からこうした材料が全て完全に除去されたことを確認しなければならないの
で、さらに多くの問題を発生しさえする。多数のステープルの線が設置されてい
る場合、外科医にとって移植可能でない材料が不用意に手術部位に取り付けられ
る危険がさらに増大する。こうした問題の各々について、内視鏡を使用する外科
医は厳しく制限された空間と道具でこうした懸念に対処しなければならない。However, with the increasing number of procedures in endoscopic surgery, access to the surgical site is deliberately limited, requiring additional cutting steps to separate the stapler from the stiffening material for the staple. That's quite annoying. In fact, PERI-S
If there is non-implantable material attached to the staple reinforcement material as is the case with TRIPS reinforcement material, the surgeon must ensure that all such material has been completely removed from the endoscopic surgical site before the procedure is terminated. You have to make sure that it causes even more problems. The presence of multiple staple lines further increases the risk of inadvertent attachment of non-implantable material to the surgical site for the surgeon. For each of these issues, endoscopic surgeons must address these concerns with tightly confined spaces and tools.
【００５２】 本発明の補強装置はこうした問題を全て解決する。第１に、装置全体が移植可
能材料から製造されているため、外科医は移植可能でない材料が不用意に患者に
取り付けられることがないことを保証できる。第２に、引き裂き線を設けること
により、外科医はステープラを手術部位から容易に分離することができ、追加切
断処置は少ないか、または全くない。実際には、引き裂き線は、ステープラアー
ムを互いに分離する動作だけで引き裂き線が完全に切断され手術部位からのステ
ープラの除去が可能になるような寸法であることが好適である。補強装置の余分
な部分は鉗子または同様の方法によって除去される。The reinforcing device of the present invention solves all of these problems. First, because the entire device is manufactured from implantable material, the surgeon can ensure that non-implantable material cannot be inadvertently attached to the patient. Second, by providing a tear line, the surgeon can easily separate the stapler from the surgical site with little or no additional cutting procedure. In practice, the tear lines are preferably sized so that the action of separating the stapler arms from each other completely cuts the tear lines to allow removal of the stapler from the surgical site. The extra portion of the stiffening device is removed by forceps or similar method.
【００５３】 さらに、特に内視鏡手術における処置の場合、自動的に補強装置が分離された
後、余分な補強材料を摘出する手段がステープラ装置に設けられることが考えら
れる。例えば、補強材料は、機械的手段（例えば、クリップ、つなぎ線等）、粘
着ストリップ等によってステープラに付着され得る。この方法では、余分な補強
材料は、ステープラと共に手術部位から自動的に除去される。Furthermore, especially in the case of procedures in endoscopic surgery, it is conceivable that the stapler device is provided with means for extracting the excess reinforcing material after the reinforcing device is automatically separated. For example, the stiffening material may be attached to the stapler by mechanical means (eg, clips, tethers, etc.), adhesive strips, etc. In this way, excess stiffening material is automatically removed from the surgical site along with the stapler.
【００５４】 図６は、スリーブ６８をステープラに付着させ、手術部位から摘出するのを容
易にする手段の２つの例を示す。図示されるスリーブ６８は本質的に矩形であり
、作用面７０と２つの引き裂き線７２ａ、７２ｂを有する。スリーブの作用面７
０の反対側の部分は、残りまたは余分の部分７６と呼ばれ、つなぎ線７８及び自
己接着性ストリップ８０の両方を有し、スリーブ６８をステープラアームに固定
する補助になる。つなぎ線７８はステープラアーム、好適にはそれに設けられた
クリップまたは同様の装置に取り付けられ、接着性ストリップは手術用アームの
背面に取り付けられる。動作の際、作用面７０が手術部位に取り付けられ、引き
裂き線７２が分離されると、残りの部分７６は、手術用ステープラアームを除去
することによって簡単に手術部位から摘出される。このようなステープラアーム
取り付け方法は単独または互いに組み合わせて利用され、手術部位からの残りの
部分が除去されることが理解されるべきである。FIG. 6 illustrates two examples of means for attaching the sleeve 68 to the stapler to facilitate removal from the surgical site. The illustrated sleeve 68 is essentially rectangular and has a working surface 70 and two tear lines 72a, 72b. Working surface of sleeve 7
The portion opposite the 0 is referred to as the remainder or extra portion 76 and has both tie lines 78 and self-adhesive strips 80 to help secure the sleeve 68 to the stapler arm. The tether 78 is attached to a stapler arm, preferably a clip or similar device provided on it, and an adhesive strip is attached to the back of the surgical arm. In operation, once the working surface 70 is attached to the surgical site and the tear line 72 is separated, the remaining portion 76 is simply excised from the surgical site by removing the surgical stapler arm. It should be appreciated that such stapler arm attachment methods may be utilized alone or in combination with each other to remove the remaining portion from the surgical site.
【００５５】 本発明の装置の実際の形状と寸法は、共に使用すべき外科装置と手順に特有の
制約により定まる。すなわち、本発明の補強装置は、円形、半円形、楕円または
他の長円形、三角形、矩形、五角形、六角形等、あるいはそれ以外の形状を含む
、事実上どんな形状または寸法にも形成される。すでに示したように、装置の面
（単数または複数）及び側面／背面の壁は完全に平面である必要はなく、折り重
ねまたは本質的に凹面または凸面を含み得る。実際、装置の何れかまたは全ての
面または壁の折り重ねまたは凹面壁構造は、スリーブによってステープラアーム
をより安定して把握するために有益になり得る。The actual shape and size of the device of the present invention will be determined by the constraints specific to the surgical device and procedure with which it is to be used. That is, the stiffening device of the present invention is formed in virtually any shape or size, including circular, semi-circular, oval or other oval, triangular, rectangular, pentagonal, hexagonal, etc., or other shapes. . As already indicated, the surface (s) and side / back walls of the device need not be perfectly planar, but may include folds or essentially concave or convex surfaces. In fact, a folded or concave wall construction of any or all faces or walls of the device can be beneficial for more stable gripping of the stapler arm by the sleeve.
【００５６】 本発明の装置は様々な種類の外科用ステープラアームに適合するため極めて多
くの異なった寸法と形状で提供されるが、その一方で本発明の装置は多様な異な
ったステープラアームの寸法と形状に対して装置を把持する手段と共に使用する
のに特に適していると考えられる。本装置の壁または面は内向きにくぼんで曲が
り（すなわち鋭角または平滑な折り目）、異なった寸法と形状のステープラアー
ムの把握動作を改良し適応性を増大することはすでに説明された。The device of the present invention is provided in a large number of different sizes and shapes to accommodate various types of surgical stapler arms, while the device of the present invention is provided with a wide variety of different stapler arm sizes. It is believed to be particularly suitable for use with means for gripping the device relative to the shape. It has been previously described that the walls or surfaces of the device bend inwardly (i.e., sharp or smooth folds) to improve the gripping action and increase flexibility of stapler arms of different sizes and shapes.
【００５７】 安全性を向上させるため、縫合線、弾性材料またはステープラが作動するまで
補強装置を定位置に保持する同様の手段を使用して、必要な寸法よりわずかに大
きい補強装置をステープラアームに固定することも可能である。こうした手段は
使用の際に外科チームによって利用されるか、または装置にあらかじめ設置され
る。To improve safety, use a suture, elastic material or similar means to hold the stiffener in place until actuation of the stapler, using a stiffener slightly larger than the required size on the stapler arm. It can also be fixed. Such means are either utilized by the surgical team at the time of use or pre-installed on the device.
【００５８】 図３には、製造業者によって補助取り付け手段を装置に組み込む方法の１つの
例が示される。この装置２６はやはり本質的に矩形のスリーブ５２であり、４つ
の作用面５４ａ、５４ｂ、５４ｃ、５４ｄを有する。この装置２６の一端の方向
に狭窄装置５６が設けられる。装置がステープラアームに設置されると、この狭
窄装置５６は、アームを把握してスリーブ５２を定位置に保持することを助ける
役目を果たす。本発明と共に使用される適切な狭窄装置には、縫合線または細い
ワイヤといった本質的に弾性のない材料、天然または合成ゴムのような弾性材料
、把握が望ましい部分でスリーブの断面を縮小する機械的または化学的手段（例
えば、スリーブに折り目を形成した後クリップ、接着剤等を使用して折り目を定
位置に保持する）等が含まれる。より広範なステープラアームに装置が容易に設
置されることと、アームへのスリーブのより確実な装着を可能にする、スリーブ
に接着されたエラストマバンドのような、少なくともある程度弾性を有する狭窄
装置が特に好適である。FIG. 3 shows one example of how a manufacturer may incorporate auxiliary attachment means into a device. The device 26 is also an essentially rectangular sleeve 52 having four working surfaces 54a, 54b, 54c, 54d. A constriction device 56 is provided toward one end of the device 26. When the device is installed on the stapler arm, the constriction device 56 serves to grasp the arm and hold the sleeve 52 in place. Suitable stenosis devices for use with the present invention include essentially inelastic materials such as sutures or fine wires, elastic materials such as natural or synthetic rubber, and mechanical materials that reduce the cross section of the sleeve where grasping is desired. Alternatively, chemical means (eg, forming folds in the sleeve and then holding the folds in place using clips, adhesive, etc.) are included. Stenosis devices that have at least some elasticity, such as elastomer bands glued to the sleeve, that allow the device to be easily installed on a wider range of stapler arms and allow for more secure attachment of the sleeve to the arm, are particularly It is suitable.
【００５９】 本発明の補強装置５８の他の例が図４に図示される。この場合、装置５８は半
円筒形スリーブ６０を備え、１つの比較的平坦な作用面６２を有する。穴開き引
き裂き線６４ａ、６４ｂが設けられ、作用面６２をバッキング材料６６から分離
することが可能になる。ここでも、装置５８全体は移植可能材料から形成されて
いるので、望ましくない材料が不用意に取り付けられることは発生しない。Another example of the reinforcement device 58 of the present invention is illustrated in FIG. In this case, the device 58 comprises a semi-cylindrical sleeve 60 with one relatively flat working surface 62. Perforated tear lines 64a, 64b are provided to allow the working surface 62 to be separated from the backing material 66. Again, since the entire device 58 is formed of implantable material, inadvertent attachment of unwanted material does not occur.
【００６０】 本発明の範囲を制限しようと意図するものではないが、以下の例はその製造及
び使用方法を例示する。Without intending to limit the scope of the invention, the following examples illustrate its method of manufacture and use.
【００６１】 実施例１ 本発明のスリーブは以下の方法で製造された。[0061] Example 1 The sleeve of the present invention was manufactured by the following method.
【００６２】 微粉末ＰＴＦＥ樹脂が、混合機の中で、コンパウンドが得られるまである量の
無臭ミネラルスピリット（Ｅｘｘｏｎ Ｃｏｒｐｏｒａｔｉｏｎから入手可能な
ＩＳＯＰＡＲ Ｍ）と結合された。微粉末ＰＴＦＥ樹脂１グラム当たりの使用さ
れるミネラルスピリットの量は約０．２６４ｃｃ／ｇであった。コンパウンドは
圧縮されてビレットとなり、ラム形押出し成形機に取り付けられた金型を通して
押出し成形され、凝集性押出し物を形成した。１２７：１の圧延比が使用された
（圧延比＝押出しシリンダの断面積÷押出し金型の断面積）。Finely powdered PTFE resin was combined in a mixer with an amount of odorless mineral spirits (ISOPAR M available from Exxon Corporation) until a compound was obtained. The amount of mineral spirits used per gram of finely powdered PTFE resin was about 0.264 cc / g. The compound was compressed into a billet and extruded through a mold attached to a ram extruder to form a coherent extrudate. A rolling ratio of 127: 1 was used (rolling ratio = cross section of extrusion cylinder ÷ cross section of extrusion die).
【００６３】 金型は、選択的に脆弱化されたコーナを伴う本質的に矩形の断面を有する完成
品スリーブを供給するような寸法であった。この金型の断面が図７に示される。
見られるように、金型８２は矩形のギャップ８４を有し、それを通してチューブ
が伸張される。ギャップは、各作用面８６ａ、８６ｂ、８６ｃ、８６ｄに沿った
約０．３７５ｍｍの第１の厚さと、各コーナ８８ａ、８８ｂ、８８ｃ、８８ｄの
約０．１２ｍｍの第２の薄い方の厚さとを有する。The mold was dimensioned to provide a finished sleeve having an essentially rectangular cross section with selectively weakened corners. The cross section of this mold is shown in FIG.
As can be seen, the mold 82 has a rectangular gap 84 through which the tube is stretched. The gap has a first thickness of about 0.375 mm along each working surface 86a, 86b, 86c, 86d and a second thinner thickness of about 0.12 mm at each corner 88a, 88b, 88c, 88d. Have.
【００６４】 押出し成形後、無臭ミネラルスピリットは揮発され、スリーブから除去された
。次に２．１８：１の比と約１０００％／秒の膨張率で管状スリーブの膨張が行
われた。膨張は約３００℃の温度の高温炉の中で行われた。次にこのスリーブに
は、スリーブを約３５０℃の温度に約７０秒間さらすことによるアモルファス固
定が行われた。After extrusion, the odorless mineral spirits were volatilized and removed from the sleeve. The tubular sleeve was then expanded at a ratio of 2.18: 1 and an expansion rate of about 1000% / sec. Expansion was performed in a high temperature furnace at a temperature of about 300 ° C. The sleeve was then subjected to amorphous fixation by exposing the sleeve to a temperature of about 350 ° C. for about 70 seconds.
【００６５】 結果として得られたスリーブは次の特性を有した。 平均フィブリル長さ：２〜５μｍ 膨張／拡張比：２．１８：１ 縦強度：約１５〜２０Ｋｇ 横強度：約５〜１０Ｋｇ 作用面厚さ：約０．３７５ｍｍ コーナ（引き裂き線）厚さ：約０．１２ｍｍ[0065] The resulting sleeve had the following properties. Average fibril length: 2-5 μm Expansion / Expansion ratio: 2.18: 1 Longitudinal strength: about 15-20Kg Lateral strength: About 5-10Kg Working surface thickness: About 0.375 mm Corner (tear line) thickness: about 0.12 mm
【００６６】 実施例２ 実施例１によって製造されたスリーブが吻合外科用ステープラの２つのアーム
に各々１つ取付けられた。次にこのステープラが使用され、実験動物の肺容量縮
小術が行われた。スリーブは容易に取付けられ、切断及びステープル固定される
ことが判明した。２組のスリーブを各々取り付けた後、横方向張力を加える鉗子
を使用して引き裂き線に沿ってスリーブを引き裂くだけで、バッキング材料はス
リーブの取り付け部分から容易に除去された。分離は容易に発生し、延伸膨張Ｐ
ＴＦＥ材料の細断は引き裂き線に沿ってごくわずか発生しただけであった。Example 2 The sleeve produced according to Example 1 was attached to each of the two arms of the anastomotic surgical stapler. The stapler was then used to perform lung volume reduction surgery on experimental animals. It has been found that the sleeve is easily installed, cut and stapled. After each of the two sets of sleeves was attached, the backing material was easily removed from the attachment portion of the sleeve simply by tearing the sleeve along the tear line using lateral tensioning forceps. Separation easily occurs, stretching expansion P
Shredding of the TFE material occurred only slightly along the tear line.
【００６７】 一連の切開がこの方法で行われた後、肺全体が食塩水に浸漬され、ステープル
またはステープルのための補強材料の場所またはその周囲の空気の漏れが試験さ
れた。空気の漏れは検出されなかった。After a series of incisions were made in this way, the entire lung was submerged in saline and air leaks were examined at or around the staples or the location of the stiffening material for the staples. No air leak was detected.
【００６８】 本発明は外科的処置の対象で使用される。可能性のある使用方法の中には、様
々な肺切除術（例えば、肺胞性嚢胞切除、肺葉切除、気腫性嚢胞切除、楔状切除
、及び肺気腫の症状を治療するために使用されるような肺縮小術）、軟部組織損
傷及び欠損の治療（例えば、腹部または胸部壁の処置、胃腸の処置）、及び他の
多様な外科的処置（例えば、生殖器修復処置等）の道具としての使用がある。装
置は吻合ステープラまたは非吻合ステープラの何れかと共に使用される。当然、
本発明の装置は人間及び動物両方の手術に伴って使用される。The present invention finds use in the subject of surgical procedures. Some possible uses include various lung resections (such as those used to treat symptoms of alveolar cystectomy, lobectomy, emphysematous cystectomy, wedge resection, and emphysema). Pulmonary reduction surgery, treatment of soft tissue injuries and defects (eg, abdominal or chest wall procedures, gastrointestinal procedures), and use as a tool for a variety of other surgical procedures (eg, genital repair procedures, etc.) . The device is used with either anastomotic staplers or non-anastomotic staplers. Of course,
The device of the present invention is used in conjunction with both human and veterinary surgery.
【００６９】 本発明の装置は、図５に示されるように対になって使用されるが、ある処置の
一方だけを補強するために使用することもまた有益であると考えられていること
が認識されるべきである。例えば、弱い材料が比較的強い材料に取り付けられて
いる（すなわち、ステープル線に沿って裂けやすい比較的弱い組織または補綴装
置が、それほど裂ける傾向のない比較的強い組織または装置に取り付けられてい
る）場合、装置は組織または装置を接合している外科的継ぎ目の片側だけに取付
けられることがある。こうした場合、本発明の装置は、ステープルによる損傷を
受けやすい材料だけを保護するように供給される。継ぎ目の完全な状態を損なう
ことなく、これによって継ぎ目全体をより薄くすることが可能になり、患者内に
配置される材料の量が減少する。Although the devices of the present invention are used in pairs as shown in FIG. 5, it may also be considered beneficial to use them to reinforce only one of the procedures. Should be recognized. For example, a weak material is attached to a relatively strong material (ie, a relatively weak tissue or prosthetic device that is prone to tearing along the staple line is attached to a relatively strong tissue or device that is less prone to tearing) In some cases, the device may be attached to only one side of the tissue or surgical seam joining the devices. In such cases, the device of the present invention is provided to protect only those materials that are susceptible to staple damage. This allows for a thinner overall seam without compromising the integrity of the seam, reducing the amount of material placed within the patient.
【００７０】 様々な他の材料が本発明のステープル補強装置に追加され、有用性を追加する
ことがあることに注意すべきである。例えば、抗菌性または抗生剤がスリーブに
塗布され、かつ／またはその多孔性構造内に充填され、感染の予防を助けること
がある。これは、微生物または細菌の感染が起こりやすい様々な処置（例えば、
腸切除、外傷（例えば、胸部または腹部の外傷）等）で特に有益であると考えら
れる。他の有益な添加剤には、接着剤、放射性可視コンパウンド、凝固剤、治癒
促進剤、癌治療剤等が含まれる。It should be noted that various other materials may be added to the staple reinforcement device of the present invention to add utility. For example, an antimicrobial or antibiotic agent may be applied to the sleeve and / or filled within its porous structure to help prevent infection. This is due to the variety of treatments that are susceptible to microbial or bacterial infection (eg,
Intestinal resection, trauma (eg, chest or abdominal trauma), etc. are considered to be particularly beneficial. Other beneficial additives include adhesives, radioactive visible compounds, coagulants, healing promoters, cancer therapeutics and the like.
【００７１】 すでに示したように、本発明を内視鏡手術によるステープラ装置について使用
する場合特別な問題がある。図８に通常の内視鏡手術用ステープラ９０が示され
るが、これは、Ｅｔｈｉｃｏｎ Ｅｎｄｏ−Ｓｕｒｇｅｒｙから入手可能なＥＮ
ＤＯＰＡＴＨ胸部内視鏡手術用ライナ切断機（ＥＺ４５型）である。この装置は
一例としてのみ使用されているのであって、本発明は様々な製造業者と形式の内
視鏡手術用ステープラで有効に利用されることが認識されるべきである。As already indicated, there are particular problems when using the present invention with endoscopic surgical stapler devices. A conventional endoscopic surgical stapler 90 is shown in FIG. 8, which is an EN available from Ethicon Endo-Surgery.
It is a liner cutting machine (EZ45 type) for thoracic endoscopic surgery. It should be appreciated that this device is used by way of example only and that the present invention may be effectively utilized with various manufacturers and types of endoscopic surgical staplers.
【００７２】 内視鏡手術用ステープラ９０は通常、ハンドル９２、閉鎖トリガ９４、打ち出
しトリガ９６、延長棒９８及びステープラヘッド９９を備えている。ステープラ
ヘッド９９は、ピボット１０４の位置で共に結合された第１顎１００、第２顎１
０２を備えている。顎の１つまたは両方はピボット１０４を中心にして移動する
ため、顎１００、１０２は切断及び封鎖される組織の周囲で共にに閉じられる。
顎の１つ（この場合、第２顎１０２）には、組織を通して打ち出されるステープ
ルを収容するカートリッジ１０６がある。反対側の顎（この場合、第１顎１００
）はステープルを正しい位置に曲げるアンビルである。図示されるステープラ９
０では、ハンドル９２に顎開放ボタン１０８が設けられ、ステープラの顎が適当
な時だけ確実に開かれるようになっている。The endoscopic surgical stapler 90 typically comprises a handle 92, a closure trigger 94, a firing trigger 96, an extension rod 98 and a stapler head 99. The stapler head 99 includes a first jaw 100 and a second jaw 1 which are joined together at the position of the pivot 104.
It is equipped with 02. As one or both of the jaws move about the pivot 104, the jaws 100, 102 are closed together around the tissue to be cut and sealed.
One of the jaws, in this case the second jaw 102, has a cartridge 106 containing staples that are driven through the tissue. Opposite jaw (in this case the first jaw 100
) Is an anvil that bends staples in place. Illustrated stapler 9
At 0, the handle 92 is provided with a jaw opening button 108 to ensure that the jaws of the stapler are opened only when appropriate.
【００７３】 内視鏡手術によるステープラの適用例には固有の多数の問題がある。第１に、
ヘッド９９のピボット１０４の付着物が問題である。ヘッド９９は（図１に例示
されているもののような）従来のステープラのアームより小型であるため、組織
がピボット１０４にはさまれる可能性が増大する。この組織はピボットの付着物
になり、装置の正しい動作を妨げることがある。内視鏡手術用ステープラは体内
で遠隔的に操作されており、正確な位置決めと組織の操作が非常に困難であるた
め、この問題は更に悪化する。There are a number of problems inherent in endoscopic surgical stapler applications. First,
The deposit on the pivot 104 of the head 99 is a problem. The head 99 is smaller than the arms of a conventional stapler (such as the one illustrated in FIG. 1), increasing the likelihood that tissue will be pinched by the pivot 104. This tissue can become a deposit on the pivot and prevent proper operation of the device. This problem is exacerbated because endoscopic surgical staplers are remotely manipulated within the body, making precise positioning and tissue manipulation very difficult.
【００７４】 第２に、装置が遠隔操作されるという性質は補強材料の提供することに関して
も問題となる。別個のスリーブが各顎に供給されるが、顎が小さいという性質は
ステープラを遠隔的に操作しなければならないという事実と結び付き、その結果
、スリーブを顎に確実に取り付けることは重要な問題点となっている。別個のス
リーブを各顎に別々に摩擦ばめすることにより多くの適用例の場合十分であるが
、外科医は一般に、患者の体内でステープラを操作する際スリーブが不用意に脱
落することがないというより大きな保証を必要とする。Secondly, the remotely controlled nature of the device also poses a problem with the provision of reinforcing materials. Separate sleeves are provided for each jaw, but the small jaw nature is tied to the fact that the stapler must be operated remotely, and as a result ensuring that the sleeve is securely attached to the jaws is an important issue. Has become. While the separate friction fit of a separate sleeve to each jaw is sufficient for many applications, surgeons generally do not inadvertently drop the sleeve when manipulating the stapler within the patient's body. Need greater assurance.
【００７５】 第３に、図８に見られるように、第１及び第２顎の寸法は非対称であることが
多く、カートリッジ１０６を担持する顎は一般にアンビル顎より大きい。この寸
法の差は摩擦ばめだけによって補強スリーブを定位置に保持することを困難にす
る一因となっており、各ステープラの形式に応じて２つの異なった寸法のスリー
ブが必要になる。Third, as seen in FIG. 8, the dimensions of the first and second jaws are often asymmetrical and the jaws carrying the cartridge 106 are generally larger than the anvil jaws. This dimensional difference contributes to the difficulty of holding the reinforcing sleeve in place by friction fit alone, requiring two different sized sleeves for each type of stapler.
【００７６】 こうした問題は全て、図９に例示されるような本発明の内視鏡手術による補強
スリーブ１１０によって対処されている。内視鏡手術用スリーブ１１０は、第１
ステープラ顎１００上で摺動されるのに適した第１スリーブ要素１１２と、もう
１つのステープラ顎１０２上で摺動されるのに適した第２スリーブ要素１１４と
を備えている。例示される好適実施形態では、各スリーブ要素１１２、１１４は
、一般に寸法と形状が顎１００、１０２に一致する本質的に矩形の形状を備えて
いる。各スリーブ要素１１２、１１４には、それぞれ作用面１１６、１１８が含
まれ、それを通してステープルが取り付けられる。All of these issues are addressed by the endoscopic surgical stiffening sleeve 110 of the present invention as illustrated in FIG. The first sleeve 110 for endoscopic surgery is
It comprises a first sleeve element 112 suitable for sliding on the stapler jaw 100 and a second sleeve element 114 suitable for sliding on another stapler jaw 102. In the preferred embodiment illustrated, each sleeve element 112, 114 comprises an essentially rectangular shape that generally conforms in size and shape to the jaws 100, 102. Each sleeve element 112, 114 includes a working surface 116, 118, respectively, through which staples are attached.
【００７７】 ２つのスリーブ要素１１２、１１４は、作用面１１６、１１８を結合するヒン
ジ１１９によって互いに結合される。ヒンジ１１９は多様な方法によって構成さ
れるが、それには、材料の同じ連続細片から２つの作用面１１６、１１８を形成
すること、または２つ以上の別個の材料片を接着し、２つのスリーブ要素１１２
、１１４の間を結合することが含まれる。The two sleeve elements 112, 114 are joined together by a hinge 119 which joins the working surfaces 116, 118. Hinge 119 may be constructed in a variety of ways, including forming two working surfaces 116, 118 from the same continuous strip of material, or adhering two or more separate pieces of material to two sleeves. Element 112
, 114 is included.
【００７８】 各スリーブ要素１１２、１１４にはそれぞれバッキング材料１２０、１２２が
含まれ、各スリーブ要素を顎に保持する。前に説明された補強スリーブの実施形
態でもそうだったように、スリーブ要素には引き裂き線１２４ａ、１２４ｂ、１
２４ｃ、１２４ｄが含まれ、患者に取付けられた後、作用面１１６、１１８から
バッキング材料１２０、１２２を分離するのを補助することが望ましい。ここで
も、切り口１２６が引き裂き線１２４に設けられ、分離が補助され得る。Each sleeve element 112, 114 includes a backing material 120, 122, respectively, to retain each sleeve element on the jaw. As was the case with the previously described reinforcing sleeve embodiments, the sleeve elements have tear lines 124a, 124b, 1
Desirably, 24c, 124d are included to assist in separating the backing material 120, 122 from the working surfaces 116, 118 after attachment to the patient. Again, a cut 126 may be provided in the tear line 124 to aid in separation.
【００７９】 この方法での補強スリーブの構成は、内視鏡手術による適用例の場合、他のス
リーブの構成に対して非常に多くの利点を有している。第１に、ピボット１０４
への接近を阻止する材料セグメントとして、ヒンジ１１９は組織がピボット１０
４に移動することに対する障壁となる。すなわち、ステープラを操作する時、付
着物または他のものによって汚染される可能性が大きく減少する。第２に、ヒン
ジ１１９は、患者内での操作中スリーブを定位置に保持する助けとなる卓越した
機能を有する。以下より詳細に説明されるように、内視鏡手術用スリーブ１１０
が使用される場合、２つのスリーブ要素１１２、１１４は顎１００、１０２上を
摺動されるだけでよく、少なくとも１つの顎において単に摩擦ばめが必要とされ
るだけである。２つのスリーブ要素がヒンジ１１９の位置で互いに取り付けられ
ているため、操作中顎上のスリーブ１１０は非常に確実に保持される。これは、
顎が互いに分離された場合、すなわち個々のスリーブが顎から非常に落ちやすい
時特に言えることである。The construction of the reinforcing sleeve in this way has numerous advantages over other sleeve constructions in the case of endoscopic surgical applications. First, the pivot 104
As a material segment that blocks access to the hinge, the hinge 119 allows the tissue to pivot.
Barriers to moving to 4. That is, when operating the stapler, the likelihood of contamination by deposits or other things is greatly reduced. Second, the hinge 119 has an outstanding function that helps hold the sleeve in place during manipulation within the patient. As will be described in more detail below, endoscopic surgical sleeve 110
If two are used, the two sleeve elements 112, 114 need only be slid over the jaws 100, 102, and only a friction fit is required in at least one jaw. Since the two sleeve elements are attached to each other at the location of the hinge 119, the sleeve 110 on the jaw during operation is held very securely. this is,
This is especially true when the jaws are separated from each other, ie when the individual sleeves are very likely to fall off the jaws.
【００８０】 本発明の内視鏡手術用スリーブ１１０の取付け方法が図１０〜図１２に例示さ
れる。図１０に示されるように、スリーブ１１０はヒンジ１１９を中心に折り畳
まれた状態で配置され、各スリーブ要素１１２、１１４は各顎部材１００、１０
２に位置合わせされる。この位置からスリーブ１１０は、図１１に示されるよう
に簡単に顎部材１００、１０２上を摺動される。図１２に示されるように、ステ
ープラヘッド９９に取付けられると、ヒンジ１１９はステープラのピボット１０
４に当接する。これによって組織がピボット１０４に付着することを避ける有効
な遮蔽物が提供される。さらに、ヒンジ１１９は、顎１００、１０２が図示され
るような開放位置にある時、スリーブ１１０がステープラヘッド９９から分離し
ないことを保証する。A method of attaching the sleeve 110 for endoscopic surgery of the present invention is illustrated in FIGS. 10 to 12. As shown in FIG. 10, the sleeve 110 is arranged in a folded state about a hinge 119, and each sleeve element 112, 114 has a respective jaw member 100, 10.
Aligned to 2. From this position, the sleeve 110 is simply slid over the jaw members 100, 102 as shown in FIG. As shown in FIG. 12, when attached to the stapler head 99, the hinge 119 causes the stapler pivot 10 to move.
Abut 4. This provides an effective shield that prevents tissue from adhering to the pivot 104. Moreover, the hinge 119 ensures that the sleeve 110 does not separate from the stapler head 99 when the jaws 100, 102 are in the open position as shown.
【００８１】 本発明の内視鏡手術用補強スリーブの動作が図１３〜図１５に例示される。図
１３は、顎１００、１０２が肺組織１２８の周囲で閉じている内視鏡手術用ステ
ープラ９０を示す。本発明の内視鏡手術用補強スリーブ１１０は、各顎１００、
１０２に取付けられている。内視鏡手術用鉗子１３０がスリーブ１１０に取り付
けられ、取り付け後に余分なスリーブ材料を除去する補助が行われる。The operation of the reinforcing sleeve for endoscopic surgery of the present invention is illustrated in FIGS. 13 to 15. FIG. 13 shows endoscopic surgical stapler 90 with jaws 100, 102 closed around lung tissue 128. The reinforcing sleeve 110 for endoscopic surgery of the present invention includes the jaws 100,
It is attached to 102. Endoscopic surgical forceps 130 are attached to the sleeve 110 to assist in removing excess sleeve material after attachment.
【００８２】 図１４に示されるように、組織を切断及び封鎖するステープラ９０の作動後、
バッキング材料１２０は、引き裂き線１２４に沿って作用面から引き剥がされる
ことにより除去される。この処置は反対側の顎でも繰り返され、バッキング材料
１２２が除去される。As shown in FIG. 14, after actuation of stapler 90 to cut and seal tissue,
The backing material 120 is removed by being torn from the working surface along the tear line 124. This procedure is repeated on the opposite jaw, removing the backing material 122.
【００８３】 図１５に示されるように、この処置を繰り返し行うことで、一連の補強された
ステープル縫合部１３２、１３４が健康な組織１３６に形成されると共に、一連
の補強されたステープル縫合部１３８、１４０が摘出される組織１４２に形成さ
れる。摘出される組織１４２は鉗子１３０、及び必要な場合にははさみ、また分
離を完了するために必要な場合には外科用メス１４４を使用して手術部位から容
易に除去される。As shown in FIG. 15, by repeating this procedure, a series of reinforced staple stitches 132, 134 are formed in the healthy tissue 136 and a series of reinforced staple stitches 138. , 140 are formed in the tissue 142 to be excised. The tissue 142 to be excised is easily removed from the surgical site using forceps 130 and scissors if necessary, and a scalpel 144 if necessary to complete the separation.
【００８４】 内視鏡手術用補強スリーブ１１０は何らかの適当な形状と寸法の材料から形成
される。理想的には、各スリーブ要素１１２、１１４は、一般にステープラ顎の
形状と寸法に一致するような寸法であり、それに対し摩擦ばめが行われる（顎よ
りわずかに大きくスリーブが容易に顎上で摺動される）。多くの内視鏡手術用ス
テープラに適合するため、ステープラは好適には一般に矩形断面である。ここで
も、バッキング材料はある程度へこんだ側壁を有し、スリーブをステープラ上の
定位置に保持する助けとなることが好適である。The endoscopic surgical stiffening sleeve 110 is formed from a material of any suitable shape and size. Ideally, each sleeve element 112, 114 is generally sized to match the shape and dimensions of the stapler jaws, to which a friction fit is applied (slightly larger than the jaws and the sleeve easily on the jaws). Sliding). The stapler is preferably generally rectangular in cross section, as it fits many endoscopic surgical staplers. Again, it is preferred that the backing material have some recessed sidewalls to help hold the sleeve in place on the stapler.
【００８５】 構成を容易にするために、スリーブ１１０は、２つのスリーブ要素１１２、１
１４を形成するため長手方向の中間で切断され、ヒンジ１１９の位置で２つの要
素を結合する連続作用面１１６、１１８を残す単一材料のチューブから形成され
得る。このようにすることにより、装置は連続材料のチューブから容易に形成さ
れ、最終製品を形成するために必要な準備が最小になる。To facilitate the construction, the sleeve 110 comprises two sleeve elements 112, 1
It may be formed from a tube of unitary material that is cut midway longitudinally to form 14, leaving a continuous working surface 116, 118 that joins the two elements at the location of hinge 119. In this way, the device is easily formed from a tube of continuous material with minimal preparation required to form the final product.
【００８６】 また、内視鏡手術用補強スリーブは、互いに取り付けられる２つ以上の別個の
構成部品から形成されることもある。別個の部品同士の取り付けは、限定ではな
いが、接着剤、熱または超音波溶接、縫合等を使用することを含む多様な方法の
何れかによって達成される。別個の要素の場合、組み立てるのがより困難になる
が、この方法により、異なった寸法のスリーブ要素を供給する（すなわち、各ス
リーブ要素の寸法を非対称な寸法の顎によりよく適合させる）、異なった特性（
例えば、質感、厚さ、剛性、表面処理等）のスリーブ要素またはスリーブ要素の
一部を供給する、異なった材料の複合材であるスリーブを供給する等の改良され
た特性が提供される。The endoscopic surgical stiffening sleeve may also be formed from two or more separate components that are attached to each other. Attachment of the separate parts to each other can be accomplished by any of a variety of methods including, but not limited to, using adhesives, heat or ultrasonic welding, stitching, and the like. Although separate elements are more difficult to assemble, this method provides different sized sleeve elements (ie, the dimensions of each sleeve element are better matched to asymmetrically dimensioned jaws). Characteristic(
Improved properties are provided such as providing a sleeve element or part of a sleeve element of texture, thickness, stiffness, surface treatment, etc.), providing a sleeve that is a composite of different materials.
【００８７】 ここで説明された内視鏡手術用補強スリーブは、主として内視鏡手術用ステー
プラ装置において使用されることを意図している。しかし、２つのスリーブ要素
と結合用ヒンジを有する補強スリーブは、ステープラアームが回転式に結合され
ている従来の外科用ステープラにも応用できることが認識されるべきである。す
なわち、「顎」及び「アーム」という語はここでは区別なく使用され、組織また
は他の材料を取り囲みそれを通してステープルを適用するために使用されるステ
ープラ部材を意味するよう意図される。The endoscopic surgical reinforcement sleeves described herein are primarily intended for use in endoscopic surgical stapler devices. However, it should be appreciated that the stiffening sleeve with the two sleeve elements and the joining hinge may also be applied to conventional surgical staplers in which the stapler arms are rotationally joined. That is, the terms "jaw" and "arm" are used interchangeably herein and are intended to mean a stapler member that is used to surround tissue or other material and apply staples therethrough.
【００８８】 本発明の特有の実施形態がここでは例示され説明されたが、本発明はそのよう
な例示及び説明に限定されるものではない。変更及び修正が、特許請求の範囲内
の本発明の一部として組み込まれかつ実施されることが明らかであろう。While specific embodiments of the present invention have been illustrated and described herein, the present invention is not limited to such illustrations and descriptions. It will be apparent that changes and modifications are incorporated and implemented as part of the invention within the scope of the claims.
【図１】 ステープラアームに取付けられた２つの本発明の外科用ステープル補強装置を
有する外科用ステープラの透視図である。1 is a perspective view of a surgical stapler having two inventive surgical staple stiffening devices attached to a stapler arm. FIG.
【図２】 本発明の外科用ステープル補強装置の１つの実施形態の４分の３等角投影図で
ある。FIG. 2 is a three-quarter isometric view of one embodiment of the surgical staple reinforcement device of the present invention.
【図３】 本発明の外科用ステープル補強装置の別の実施形態の４分の３等角投影図であ
る。FIG. 3 is a three-quarter isometric view of another embodiment of the surgical staple reinforcement device of the present invention.
【図４】 本発明の外科用ステープル補強装置の別の実施形態の４分の３等角投影図であ
る。FIG. 4 is a three-quarter isometric view of another embodiment of the surgical staple reinforcement device of the present invention.
【図５】 ステープラ装置の作動直後に組織の両側に取り付けられたことが示される本発
明の２つの外科用ステープル補強装置の透視図であるが、補強装置は部分的に分
離されて図示され、ステープラはわかりやすくするため図示されていない。FIG. 5 is a perspective view of two surgical staple reinforcement devices of the present invention shown mounted on both sides of tissue immediately after actuation of the stapler device, but with the reinforcement devices shown partially separated; The stapler is not shown for clarity.
【図６】 本発明のステープル補強装置の別の実施形態の４分の３等角投影図である。[Figure 6] FIG. 6 is a three-quarter isometric view of another embodiment of a staple reinforcing device of the present invention.
【図７】 本発明の補強装置の１つの実施形態の製造に適した押出し金型の一実施形態の
断面図である。FIG. 7 is a cross-sectional view of one embodiment of an extrusion mold suitable for manufacturing one embodiment of the reinforcement device of the present invention.
【図８】 市販の内視鏡ステープラ装置の側面立面図である。[Figure 8] FIG. 3 is a side elevational view of a commercially available endoscopic stapler device.
【図９】 本発明の内視鏡手術用ステープル補強装置の４分の３等角投影図である。[Figure 9] FIG. 4 is a three-quarter isometric view of the endoscopic surgical stapler of the present invention.
【図１０】 内視鏡手術用ステープラ顎に取付けられた本発明の内視鏡手術用ステープル補
強装置の側面立面図である。FIG. 10 is a side elevational view of the endoscopic surgical stapler device of the present invention attached to an endoscopic surgical stapler jaw.
【図１１】 内視鏡手術用ステープラ顎上で摺動された本発明の内視鏡手術用ステープル補
強装置の側面立面図である。FIG. 11 is a side elevational view of the endoscopic surgical stapler device of the present invention slid over the jaws of the endoscopic surgical stapler.
【図１２】 内視鏡手術用ステープラ顎に完全に取付けられた本発明の内視鏡手術用ステー
プル補強装置の側面立面図であるが、顎は開放位置で図示されている。FIG. 12 is a side elevational view of the endoscopic surgical stapler apparatus of the present invention fully attached to an endoscopic surgical stapler jaw, but with the jaw shown in an open position.
【図１３】 組織周囲の位置に締め付けられたことを示す本発明の内視鏡手術用ステープル
補強装置の４分の３等角投影図であるが、内視鏡手術用ステープラ顎は閉じて固
定された位置で図示されている。FIG. 13 is a three-quarter isometric view of the endoscopic surgical stapling apparatus of the present invention showing that it has been clamped around tissue, but with the endoscopic stapler jaws closed and secured; It is shown in the closed position.
【図１４】 図１３に示される内視鏡手術用ステープル補強装置と内視鏡手術用ステープラ
顎の４分の３等角投影図であるが、余分な材料は手術部位から除去されている。FIG. 14 is a three-quarter isometric view of the endoscopic stapler reinforcement device and endoscopic stapler jaw shown in FIG. 13, but with excess material removed from the surgical site.
【図１５】 内視鏡手術用ステープラと本発明の補強装置を使用して切断及び封鎖された組
織の４分の３等角投影図である。FIG. 15 is a three-quarter isometric view of tissue cut and blocked using an endoscopic surgical stapler and a stiffening device of the present invention.
─────────────────────────────────────────────────────フロントページの続き (81)指定国 ＥＰ(ＡＴ，ＢＥ，ＣＨ，ＣＹ，ＤＥ，ＤＫ，ＥＳ，ＦＩ，ＦＲ，ＧＢ，ＧＲ，ＩＥ，ＩＴ，ＬＵ，ＭＣ，ＮＬ，ＰＴ，ＳＥ)，ＡＬ，ＡＭ，ＡＴ，ＡＵ，ＡＺ，ＢＡ，ＢＢ，ＢＧ，ＢＲ，ＢＹ，ＣＡ，ＣＨ，ＣＮ，ＣＵ，ＣＺ，ＤＥ，ＤＫ，ＥＥ，ＥＳ，ＦＩ，ＧＢ，ＧＥ，ＧＨ，ＧＭ，ＧＷ，ＨＲ，ＨＵ，ＩＤ，ＩＬ，ＩＳ，ＪＰ，ＫＥ，ＫＧ，ＫＰ，ＫＲ，ＫＺ，ＬＣ，ＬＫ，ＬＲ，ＬＳ，ＬＴ，ＬＵ，ＬＶ，ＭＤ，ＭＧ，ＭＫ，ＭＮ，ＭＷ，ＭＸ，ＮＯ，ＮＺ，ＰＬ，ＰＴ，ＲＯ，ＲＵ，ＳＤ，ＳＥ，ＳＧ，ＳＩ，ＳＫ，ＳＬ，ＴＪ，ＴＭ，ＴＲ，ＴＴ，ＵＡ，ＵＧ，ＵＺ，ＶＮ，ＹＵ，ＺＷ(72)発明者 リフル，ロブ ジー． アメリカ合衆国，アリゾナ 86004，フラ ッグスタッフ，ピント ドライブ ウエス ト 9965(72)発明者 ウォルバーン，フレデリック ジェイ． アメリカ合衆国，アリゾナ 86004，フラ ッグスタッフ リオ デ フラッグ 2000(72)発明者 ウィリアムズ，ベンジャミン ジー． アメリカ合衆国，アリゾナ 86003，フラ ッグスタッフ，ピー．オー．ボックス 2434，アルペン ランチョスＦターム(参考） 4C060 BB01 BB05 BB30 FF01 GG21 GG40 MM24─────────────────────────────────────────────────── ───Continued front page (81) Designated countries EP (AT, BE, CH, CY,DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE), AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES,FI, GB, GE, GH, GM, GW, HR, HU, ID, IL, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD,MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, UZ, VN,YU, ZW(72) Inventor Rifle, Robsey. 86004, Hula, Arizona, United States Stuff, Pinto Drive Waste To 9965(72) Inventor Walburn, Frederick Jay. 86004, Hula, Arizona, United States Gustaff Rio de Flag 2000(72) Inventor Williams, Benjamin Gee. 86003, Hula, Arizona, United States G staff, Pee. Oh. Box 2434, Alpine RanchosF-term (reference) 4C060 BB01 BB05 BB30 FF01 GG21 GG40 MM24
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/893,438 | 1997-07-09 | ||
| US08/893,438US5810855A (en) | 1995-07-21 | 1997-07-11 | Endoscopic device and method for reinforcing surgical staples |
| PCT/US1998/013643WO1999002090A1 (en) | 1997-07-09 | 1998-07-01 | Device and method for reinforcing endoscopic staple line |
| Publication Number | Publication Date |
|---|---|
| JP2003524431Atrue JP2003524431A (en) | 2003-08-19 |
| JP4002065B2 JP4002065B2 (en) | 2007-10-31 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2000501694AExpired - LifetimeJP4002065B2 (en) | 1997-07-11 | 1998-07-01 | Reinforcing sleeve for surgical stapler |
| Country | Link |
|---|---|
| US (1) | US5810855A (en) |
| EP (1) | EP0993274B1 (en) |
| JP (1) | JP4002065B2 (en) |
| AU (1) | AU737532B2 (en) |
| CA (1) | CA2294774C (en) |
| DE (1) | DE69839994D1 (en) |
| ES (1) | ES2313749T3 (en) |
| WO (1) | WO1999002090A1 (en) |
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